GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC
FDA 510(k) clearance K143592 · decided 2015-04-16
Clearance details
- K-number
- K143592
- Device name
- GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC
- Applicant
- The Surgeon General, Department of the Army
- Decision
- Substantially Equivalent
- Date received
- 2014-12-18
- Decision date
- 2015-04-16
- Days to decision
- 119 days
- Clearance type
- Special
- Product code
- NVQ
- Device class
- 2
- Regulation number
- 866.3045
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Fort Detrick, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS (K051794) | Office of the Surgeon General, U.S. Army | 2005-08-16 |
Recalls involving this device
No recalls on record reference this clearance.